Hui Zhen Chng

Optimistic, meticulous, and accountable person who is experienced in manufacturing and commercial industry of medical device. I am familiar with medical device regulation across multiple countries, such as US, Europe Malaysia, Singapore and etc., ISO13485 & ISO9001 Quality Management System, ISO10993 Biocompatibility, ISO14971 Risk Management, ISO11137/ISO11135 Sterilization Validation, ISO15223 Labelling Requirement and many more. Ready to contribute and willing to learn new knowledge in upcoming challenges and task.

Always with the aim to provide positive impact in healthcare and improve people’s lives.

Regulatory Affair Executive at Vital Healthcare Sdn. Bhd. (2023-10 – Present)

• Managed the registration of medical devices and qualification of branch companies across multiple regions, including Peru, Brazil, Ecuador, Colombia, Russia etc — covering activities such as obtaining branch operating licenses, warehouse storage permits, recruiting technical directors, and sourcing local consultants.
• Respond to the queries and keep track on the status of applications.
• Handled regulatory activities in EU countries, including change notifications, EU FSC and familiar with EU MDCG guidance.
• Maintained effective communication with internal stakeholders (headquarters and regional teams) and external partners (EU/UK Representatives and regulatory consultants).
• In charge of UDI creation and reporting to GS1 Organization, ensuring accuracy and compliance with global UDI requirements.
• Coordinated customer or distributor registration processes in various countries, such as Egypt, Korea, and Serbia.
• Led US FDA and EU MDR registration activities, supporting regulatory compliance and product market entry.
• Exposed to product design development, such as validation, biocompatibility.

Junior Regulatory Affair at Biomed Global (2021-12 – 2023-10)

• Developed proficient in Exemption (Special Access, Demo, Clinical Research Use)
• Handled Change Notification when there is change in the medical device.
• Achieved strong expertise in Pre-market (Medical Device Assessment, Risk Classification, Registration of In Vitro Diagnostics & General Medical Device) & Post market (Adverse Event, Field Safety Corrective Action, Recall)
• Attended ISO13485& ISO9001 audit training and carried out internal audit.
• Attended MDA/MMDA seminar & training to receive latest update of Malaysia regulation.
• Involved in submission of HSA medical device exemption (GN27, GN29).
• Possess good communication skills to liaise with internal and external stakeholders.

Final Year Project (2020-10 – 2021-07)

• Developed technical skills in performing bioinformatics (BIOVIA and HADDOCK software) and spectrophotometric analysis (antioxidant assay and cell viability assay).
• Established cell culture technique, specifically subculturing, cell counting, cryopreservation and preparation of culture media.
• Strengthened the skills in using SPSS software for statistical analysis as well as word processing and spreadsheet software such as Microsoft Excel and Words for producing charts and graph, result analysis and thesis writing.

GeniusOrganic Enterprise (2020-07 – 2020-09)

• Engaged with customers by delivering friendly customer service and promoting suitable organic food based on their needs.
• Reviewed and improved the sales performance and communication in order to build good relationship with customer and deliver product information effectively.
• Managed inventory control by maintaining organized file systems, such as document filing and arranging.

University Malaya Medical Centre (2019-07 – 2019-07)

• Actively assisted the medical laboratory technicians to do laboratory task and developed technical skills, such as sample acknowledgement, sample centrifugation and loading.
• Cultivated laboratory safety and quality management skills in order to produce accurate and reliable result under safe condition with the adherence to the ISO standards and policy (ISO15189).
• Applied the knowledge learnt about Phlebotomy, such as uses of vacutainer tube when handling samples.

Bachelor in Biomedical Science – University of Malaya (2017-09 – 2021-07)

Matriculation (2016-06 – 2017-04)

Secondary School – SMJK Jit Sin (2011 – 2015)